Safety, pharmacokinetics and efficacy of bimagrumab in overweight and obese patients with type 2 diabetes
- Conditions
- Diabetes Mellitus, Type 2MedDRA version: 20.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2016-004124-26-GB
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 78
- Type 2 diabetes with HbA1c between 7% and 10% at screening with stable treatment for 3 months prior to randomization
- Body Mass Index of 28 to 40 kg/m2 at screening
- Body weight between 65 and 140 kg at screening
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
- Women of child-bearing potential unless they are using highly effective methods of contraception
- Diabetes other than Type 2 such as Type 1 diabetes, surgically induced diabetes, brittle type 2 diabetes as per investigator judgement, history of severe hypoglycemic episodes in the year preceding screening or hypoglycemic unawareness
- history of clinically significant arrythmias, heart failure, unstable angina, myocardial infarction or stroke, coronary artery bypass graft surgery, or percutaneous coronary intervention, deep vein thrombosis/pulmonary embolism, valve disorders or defects, pulmonary hypertension within 6 months of screening or 1 year for drug-eluting stents
- tachycardia
- use of anti-obesity medications, nutritional supplements or over the counter products ofr weight loss within 3 months of screening
- use of medications known to induce weight gain such as some anti-convulsant and psychotropic medications within 3
months of screening
- Any chronic active infection (e.g., HIV, Hepatitis B or C, tuberculosis, etc)
- uncontrolled thyroid disease. Stable euthyroid patients on stable thyroid replacement therapy for at least 3 months of
screening are allowed
- Known history or presence of severe active acute or chronic liver disease (e.g., cirrhosis)
- Uncontrolled depression
- Use of skeletal muscle anabolic agents in any form for 3 months prior to screening
- Chronic kidney disease [estimated glomerular filtration rate (GFR) < 30 mL/min]
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the treatment effect of bimagrumab on total body fat mass;Secondary Objective: - To evaluate the treatment effect of bimagrumab on total body fat mass after 6 months of treatment<br>- To evaluate the treatment effect of bimagrumab on glycemic control and parameters of insulin sensitivity<br>- To evaluate the safety and tolerability of bimagrumab in overweight and obese subjects with type 2 diabetes<br>- To evaluate the pharmacokinetics of repeat doses of bimagrumab in overweight and obese subjects with type 2 diabetes<br>- To evaluate the immunogenic response to repeat dosing of bimagrumab in overweight and obese subjects with type 2 diabetes<br>- To evaluate the treatment effect of bimagrumab on anthropometric body measurements and on lean body mass;Primary end point(s): Change in total body fat mass measured by DXA at week 48;Timepoint(s) of evaluation of this end point: Week 48
- Secondary Outcome Measures
Name Time Method